虽然有创和无创工具的观察数据表明,CFR完整的病灶表现良好,但这些研究很少同时评估FFR。这些文献大多来自单一中心/国家的经验,这限制了其普遍性。此外,由于操作人员各自决定了治疗方式,给后续的临床结果带来潜在混淆。为了解决现有文献的这些局限性,我们设计并实施了DEFINE-FLOW研究(clinicaltrials.gov NCT02328820)。...
312.8 Charging for investigational drugs under an IND. (a)General criteria for charging . (1) A sponsor must meet the applicable requirements in paragraph (b) of this section for charging in a clinical trial or paragraph (c) of this section for charging for expanded access to an ...
·临床试验特定声明: 寻求适用临床试验的知情同意时,必须向每位临床试验受试者提供以下声明,以通知他们临床试验信息已经或将被提交给临床试验注册数据库:「本临床试验的描述将在http://www.ClinicalTrials.gov上提供,这是美国法律的要求。这个网站不会包括可以识别您的信息。至多,网站将包括结果的摘要。您可以随时在这...
大部分临床医学研究 Most clinical trials 没有采用数据标准化 dont employ a standard for data exchange 没有使用标准化的工具和技术 dont use standardized analytic tools or techniques p 后果Result其结果是造成了临床数据分析中效率和系统化的困难,特别是对多个临床试验Analyzing clinical trial data efficiently an...
NMRFocuses on the 21 CFR 11 requirements for the clinical trials data of pharmaceutical companies in the U.S. Efficacy of 21 CFR 11; Appropriate controls required by the files; Importance of 21 CFR 11.Canale...
是CODE OF FEDERAL REGULATION美国)联邦法规吗?
•Setofregulationsgoverningconductofclinicaltrialsinemergencysituationswithexceptionfromtherequirementsforinformedconsent 21CFR50.24(a)(2)•subjectsmustbeinalife-threateningsituationforwhichavailabletreatmentsareunsatisfactory/unproven•needtocollectvalidscientificevidence…todeterminethesafetyandeffectivenessofparticular...
(b), and 520(l) of the act with respect to the classification and reclas- sification of devices intended for human use. (b) This part prescribes the criteria and procedures to be used by classifica- tion panels in making their rec- ommendations and by the Commis- sioner in making ...
Supports remote consentingfor decentralized clinical trials (DCTs). Run Your Operation Seamlessly eConsent integrated with our entireSite Operation Management System (SOMS). Eliminate missing consent deviations, one of the FDA’s most common 483 findings. ...
manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity. We supply our training to clinical research, pharmaceutical, and medical device industries. Employee / Corporate Training:For corporations seeking a method to train employees...